Panther Fusion Tube Tray recall
Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
Why was Panther Fusion Tube Tray recalled?
Tube trays may leak which could invalidate patient results or assay worklists, causing delayed results for any assays with which they are used. A possibility exists of false negative result with flu A/B/RSV assay or paraflu assay.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Box/ Tray lots: 271436/ 618539, 271438/ 620899, 272089/ 620899, 272959/ 621837, 272970/ 621256, 272971/ 621837, 274670/ 625351
- Product
- Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
- Recalling firm
- Hologic, Inc
- Quantity
- 607
- Distribution
- U.S. :ID, SC, VT, CA, IL, UT, NJ, MA, TX, AL, CO, FL, ME, NY, VA, WA, WI, OR, DC, GA, NC, HI, CT, OK, TN, O.U.S.: CA, SE, GB, DE, DO, IT, ES, NO, BE, NL, FR, DK, AT
- Recall date
- September 30, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)